Overview
Quality Assurance Specialist Jobs in Simi Valley, CA at Kindeva Drug Delivery
Title: Quality Assurance Specialist
Company: Kindeva Drug Delivery
Location: Simi Valley, CA
Kindeva Drug Delivery is a global pharmaceutical contract developer and manufacturing (CDMO) business. This position is for a Quality Assurance Specialist for our Northridge operations. Our Northridge site manufactures and packages pharmaceutical products.
The Impact You Will Make
This is a great opportunity to make an impact in our Quality group by reviewing completed batch manufacturing orders before the release of finished product. This will ensure compliance with appropriate internal procedures and regulatory expectations.
Job Responsibilities
Reviews completed batch manufacturing orders and analytical reports for accuracy, completeness, and compliance
Reviews raw materials and semi-finished goods for use in production
Dispositions (release/reject) materials and products in Microsoft D365 and StarLims
Carefully reviews raw material paperwork to ensure rest and expiration dates are correct
Assigns expiration dates on manufacturing documents and in the inventory management system
Processes transactions in the inventory management system (D365) for material or item status changes per Material Status Disposition process
Uploads manufacturing and quality documentation to Sharepoint sites for customer review
Prepares and issues Manufacturing Orders to production
Support and participate in internal/external audits
Files Batch Records and other critical documents in the Documentation Center
Attends quality management and product planning/scheduling meetings
Support continuous improvement activities within the Quality Department and the Northridge facility.
Required Skills And Experience
High school level of education
Between 2+ years of related job experience
Proficient computer skills (MS Word, Excel)
Good organizational skills
Good communication skills (verbal, written)
Good time management skills
Ability to work independently, self-motivated, and flexible
Works well in a team environment
Preferred Skill And Experience
Knowledge of basic cGMPs and quality systems
California residents should review our
Notice for California Employees and Applicants
before applying.
The expected compensation range for this position represents a good faith estimate. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, & Vision, Health Savings Accounts, Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences, and 401k Benefits, etc.).
Equal Opportunity Employer
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
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